The MAA includes the data from a comprehensive U.S. Phase III clinical program in procedural sedation in patients undergoing bronchoscopy or colonoscopy. In a pre-submission meeting with the EMA held earlier this year, the agency indicated that these data would be sufficient for submitting an MAA in procedural sedation. The MAA review process typically takes about one year.

Assuming approval in procedural sedation and positive results in the ongoing EU Phase III trial in general anesthesia, PAION plans to submit an extension of the marketing authorization, a so-called type-II-variation, for remimazolam for general anesthesia in Europe. The review process for an extension is generally significantly faster than for an MAA.

"The submission of our MAA to the European Medicines Agency represents another significant step towards PAION becoming a focused specialty pharmaceutical company, with our own sales & marketing capabilities" said Dr. Jim Phillips, CEO of PAION AG. "PAION and its partners now have multiple applications for Marketing Authorizations underway in all key markets worldwide, and we look forward to working with the EMA during the review process with the goal of bringing remimazolam to the market as quickly as possible."

###

About remimazolam
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic that has shown positive results in clinical Phase III trials. In the human body, remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and is not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation or anesthesia if necessary. During clinical studies, remimazolam demonstrated efficacy and safety with around 2,400 volunteers and patients. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.

PAION has completed clinical development of remimazolam for procedural sedation in the U.S. The U.S. licensee Cosmo submitted a New Drug Application (NDA) in procedural sedation in the U.S. in April 2019 and is responsible for any further development activities in the U.S. In Japan, licensee Mundipharma filed for market approval in general anesthesia in December 2018. In China, licensee Yichang Humanwell filed for market approval in procedural sedation in November 2018. In Europe, PAION submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in procedural sedation in November 2019, and a Phase III trial in general anesthesia is ongoing.

In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation beyond 24 hours is another possible attractive indication for further development in the EU by PAION as well as by its licensees in other territories.

Remimazolam is partnered in the U.S. (Cosmo Pharmaceuticals), Japan (Mundipharma), China (Yichang Humanwell), Canada (Pharmascience), Russia/CIS, Turkey and the MENA region (R-Pharm) as well as South Korea (Hana Pharm). For all other markets outside the EU, remimazolam is available for licensing.

About PAION
PAION AG is a publicly listed specialty pharmaceutical company developing and aiming to commercialize innovative drugs for out-patient and hospital-based sedation, anesthesia and critical care services. PAION's lead compound is remimazolam, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic drug candidate. PAION has completed clinical development for use in procedural sedation in the U.S. and its licensee Cosmo Pharmaceuticals submitted a New Drug Application in April 2019, for which a PDUFA decision date of 05 April 2020 has been set. In Japan, licensee Mundipharma filed for market approval for remimazolam in general anesthesia in December 2018. In China, licensee Yichang Humanwell filed for market approval for remimazolam in procedural sedation in November 2018.

In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019. A Phase III trial in general anesthesia is ongoing.

Development for intensive care unit (ICU) sedation is part of the longer-term life-cycle plan for remimazolam.

PAION's vision is to become an acknowledged "PAIONeer" in sedation and anesthesia. PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).

This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG's management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from the Company's assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments.

20.11.2019 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.

Editor Details

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.

Disclaimer: You are now leaving PharmiWeb.com website and are going to a website that is not operated by us. We are not responsible for the content or availability of linked sites.

ABOUT THIRD PARTY LINKS ON OUR SITE

PharmiWeb.com offers links to other third party websites that may be of interest to our website visitors. The links provided in our website are provided solely for your convenience and may assist you in locating other useful information on the Internet. When you click on these links you will leave the PharmiWeb.com website and will be redirected to another site. These sites are not under the control of PharmiWeb.com.

PharmiWeb.com is not responsible for the content of linked third party websites. We are not an agent for these third parties nor do we endorse or guarantee their products. We make no representation or warranty regarding the accuracy of the information contained in the linked sites. We suggest that you always verify the information obtained from linked websites before acting upon this information.

Also, please be aware that the security and privacy policies on these sites may be different than PharmiWeb.com policies, so please read third party privacy and security policies closely.

If you have any questions or concerns about the products and services offered on linked third party websites, please contact the third party directly.